Psoriasis Clinical Trial
A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash).
Full Description
This is a randomized (assignment of study drug by chance), double-blind (neither the participant or study staff will know the identity of study drugs), placebo- (inactive substance identical in appearance to study drug) and active-comparator-controlled (use of an approved drug to compare with study drug) study of guselkumab. The active comparator study drug is adalimumab, an approved drug for the treatment of moderate to severe plaque psoriasis. Participants who satisfy all inclusion and exclusion criteria will be randomly assigned in a 2:1:1 ratio to one of three treatment groups (arms): Group I (guselkumab 100 mg dose regimen), Group II (placebo then crossover to guselkumab at Week 16), or Group III (adalimumab at standard psoriasis dosing). From Week 28 up to Week 76, treatment for all participants will be based on their level of response. All participants will receive guselkumab every 8 weeks from Week 76 through Week 252 with a final safety follow-up visit at Week 264 (open label treatment period). The end of the study is defined as the time the last participant completes the Week 264 visit. The total duration of the study will be approximately 268 weeks (includes a 4-week screening period). Participants will be monitored for safety throughout the study.
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis) at least 6 months before the first administration of study agent
Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (>=) 12 at Screening and at Baseline
Have an Investigator's Global Assessment (IGA) score >=3 at Screening and at Baseline
Have an involved body surface area (BSA) >=10 percent (%) at Screening and at Baseline
Must be a candidate for either systemic therapy or phototherapy for psoriasis
Exclusion Criteria:
Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular) or with current drug-induced psoriasis (for example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
Participants who have ever received guselkumab or adalimumab
History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months following the last administration of study drug
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There is 1 Location for this study
Birmingham Alabama, , United States
Bakersfield California, , United States
Los Angeles California, , United States
San Diego California, , United States
Santa Monica California, , United States
Aurora Colorado, , United States
Coral Gables Florida, , United States
Tampa Florida, , United States
Newnan Georgia, , United States
Sandy Springs Georgia, , United States
Chicago Illinois, , United States
Rolling Meadows Illinois, , United States
Skokie Illinois, , United States
Indianapolis Indiana, , United States
Plainfield Indiana, , United States
Louisville Kentucky, , United States
Andover Massachusetts, , United States
Fort Gratiot Michigan, , United States
Troy Michigan, , United States
Saint Louis Missouri, , United States
Albuquerque New Mexico, , United States
New York New York, , United States
Gahanna Ohio, , United States
Norman Oklahoma, , United States
Portland Oregon, , United States
Pittsburgh Pennsylvania, , United States
Johnston Rhode Island, , United States
Arlington Texas, , United States
Houston Texas, , United States
Salt Lake City Utah, , United States
Seattle Washington, , United States
Spokane Washington, , United States
Benowa , , Australia
Hectorville , , Australia
Melbourne , , Australia
Parkville , , Australia
Westmead , , Australia
Woolloongabba , , Australia
Barrie Ontario, , Canada
Hamilton Ontario, , Canada
Mississauga Ontario, , Canada
Ottawa Ontario, , Canada
Richmond Hill Ontario, , Canada
Toronto Ontario, , Canada
Waterloo Ontario, , Canada
Windsor Ontario, , Canada
Jihlava , , Czechia
Nachod , , Czechia
Pardubice , , Czechia
Plzen , , Czechia
Praha 10 , , Czechia
Praha 5 , , Czechia
Usti nad Labem , , Czechia
Dresden , , Germany
Gera , , Germany
Hamburg , , Germany
Kiel , , Germany
Leipzig , , Germany
Lubeck , , Germany
Munster , , Germany
Tübingen , , Germany
Witten , , Germany
Busan , , Korea, Republic of
Daejeon , , Korea, Republic of
Gwangju , , Korea, Republic of
Incheon , , Korea, Republic of
Seongnam , , Korea, Republic of
Seoul , , Korea, Republic of
Suwon , , Korea, Republic of
Bialystok , , Poland
Bydgoszcz , , Poland
Gdansk , , Poland
Krakow , , Poland
Lodz , , Poland
Lublin , , Poland
Olsztyn , , Poland
Poznan , , Poland
Poznań , , Poland
Torun , , Poland
Warszawa , , Poland
Wroclaw , , Poland
Chelyabinsk , , Russian Federation
Cherepovets , , Russian Federation
Moscow , , Russian Federation
Rostov-on-Don , , Russian Federation
Ryazan , , Russian Federation
St-Petersburg , , Russian Federation
St. Petersburg , , Russian Federation
Yaroslavl , , Russian Federation
Badalona , , Spain
Barcelona , , Spain
Bilbao Vizcaya , , Spain
Madrid , , Spain
Murcia , , Spain
Pontevedra , , Spain
Valencia , , Spain
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